Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer

NCT01827943

Last updated date
Study Location
CHU de Bordeaux
Bordeaux, , 33076, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Relapsed Bladder Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men or women of at least 18 years of age

- Histologically proven Bladder cancer

- Locally advanced or metastatic disease (stage IV)

- Functional status (ECOG / OMS) ≤ 2

- Relapse after first-line chemotherapy

- Measurable lesions (RECIST criteria)

- Absence of anti-neoplasic treatment in the 4 weeks preceding inclusion.

- Biological levels :

- Neutrophil count >1,5.109/L.

- Platelets >100.109/L

- Total serum bilirubin < 1.5 × ULN

- Clearance of créatinine 40 ml/mm

- If not liver metastasis alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 × ULN

- With liver alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 × ULN

- Signed informed consent

- Both women and men must agree to use a medically acceptable method of contraception throughout the study. Women of childbearing potential must have a negative serum pregnancy test of or less than 7 days before the first perfusion of study.

- France only : Patients affiliated to a social security program

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Presence of metastatic brain or meningeal tumors on selection scanner, weither
symptomatic or asymptomatic


- Chemotherapy, immunotherapy, or radiotherapy within 4 weeks of inclusion


- Known hypersensitivity to temsirolimus, or its metabolites (as sirolimus), or
polysorbate 80 or to their excipients


- Previous malignancy (except for cervical carcinoma in situ, basal cell carcinoma
curatively treated) or incidental (≤ pT2) prostate cancer found on a radical
cystoprostatectomy material


- The drugs known as CYP3A4/5 inhibitors or inducers will specifically be excluded on
the 30th day ( or at least 7 halves-lives, according to the shortest duration) before
the first perfusion and throughout the study. Any food known to inhibit CYP3A4/5 (for
example grapefruit, grapefruit juice, star-fruit or star-fruit juice) will also be
purposely excluded.


- Auto-immune pathology, psychiatric or neurological disorder


- Any unstable medical condition


- Unstable cardiac disease


- Severe renal failure


- Unstable diabetes


- Pregnancy


- Patient enrolled in another therapeutic clinical trial


- Patient unable to follow and comply with the study procedures because of any
geographical, social or medical condition


- Patient partially or totally deprived of his civil rights

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Relapsed Bladder CancerPhase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer
NCT01827943
  1. Bordeaux,
  2. Caen,
  3. Clermont Ferrand,
  4. Créteil,
  5. Lyon,
  6. Paris,
  7. Rouen,
  8. Toulouse,
  9. Toulouse,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer
Official Title  ICMJE Phase II Trial, Evaluating Efficacy of Temsirolimus (Torisel ®) in Second Line Therapy for Patients With Advanced Bladder Cancer
Brief Summary In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.
Detailed Description In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival. This study will also search for genes involved in the response to treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed Bladder Cancer
Intervention  ICMJE Drug: TORISEL
Temsirolimus
Study Arms  ICMJE Experimental: TORISEL
Torisel
Intervention: Drug: TORISEL
Publications * Pulido M, Roubaud G, Cazeau AL, Mahammedi H, Vedrine L, Joly F, Mourey L, Pfister C, Goberna A, Lortal B, Bellera C, Pourquier P, Houédé N. Safety and efficacy of temsirolimus as second line treatment for patients with recurrent bladder cancer. BMC Cancer. 2018 Feb 17;18(1):194. doi: 10.1186/s12885-018-4059-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2013)
55
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women of at least 18 years of age
  • Histologically proven Bladder cancer
  • Locally advanced or metastatic disease (stage IV)
  • Functional status (ECOG / OMS) ? 2
  • Relapse after first-line chemotherapy
  • Measurable lesions (RECIST criteria)
  • Absence of anti-neoplasic treatment in the 4 weeks preceding inclusion.
  • Biological levels :
  • Neutrophil count >1,5.109/L.
  • Platelets >100.109/L
  • Total serum bilirubin < 1.5 × ULN
  • Clearance of créatinine 40 ml/mm
  • If not liver metastasis alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 × ULN
  • With liver alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 × ULN
  • Signed informed consent
  • Both women and men must agree to use a medically acceptable method of contraception throughout the study. Women of childbearing potential must have a negative serum pregnancy test of or less than 7 days before the first perfusion of study.
  • France only : Patients affiliated to a social security program

Exclusion Criteria:

  • Presence of metastatic brain or meningeal tumors on selection scanner, weither symptomatic or asymptomatic
  • Chemotherapy, immunotherapy, or radiotherapy within 4 weeks of inclusion
  • Known hypersensitivity to temsirolimus, or its metabolites (as sirolimus), or polysorbate 80 or to their excipients
  • Previous malignancy (except for cervical carcinoma in situ, basal cell carcinoma curatively treated) or incidental (? pT2) prostate cancer found on a radical cystoprostatectomy material
  • The drugs known as CYP3A4/5 inhibitors or inducers will specifically be excluded on the 30th day ( or at least 7 halves-lives, according to the shortest duration) before the first perfusion and throughout the study. Any food known to inhibit CYP3A4/5 (for example grapefruit, grapefruit juice, star-fruit or star-fruit juice) will also be purposely excluded.
  • Auto-immune pathology, psychiatric or neurological disorder
  • Any unstable medical condition
  • Unstable cardiac disease
  • Severe renal failure
  • Unstable diabetes
  • Pregnancy
  • Patient enrolled in another therapeutic clinical trial
  • Patient unable to follow and comply with the study procedures because of any geographical, social or medical condition
  • Patient partially or totally deprived of his civil rights
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01827943
Other Study ID Numbers  ICMJE IB2009-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Bergonié
Study Sponsor  ICMJE Institut Bergonié
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Chair:Nadine HOUEDE, MDInstitut Bergonié
PRS Account Institut Bergonié
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP